510(k) · Cleared
ClearedPowder Free Yellow Synthetic Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Wally Plastics Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jan 30, 2014 as substantially equivalent to K110945 (Zhaoyang Plastic Co., Ltd., 2011) after a 266-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jan 30, 2014
- Review
- 266 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042119 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK042119 Powder-Free Vinyl Patient Examintion GlovesShijiazhuang Manful Light Industrial Products Co., · 2004
- 2 generations backK051156 Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005
- 1 generation backK110945 Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011
- This deviceK131344 Powder Free Yellow Synthetic Vinyl Patient Examination GlovesShijiazhuang Wally Plastics Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co., | 2004 | — |
| −2 | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co., | 2005 | — |
| −1 | K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | Zhaoyang Plastic Co., Ltd. | 2011 | — |
| 0 (this device) | K131344 | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Wally Plastics Co., Ltd. | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesSummary page 2…icate Device Subjec IDevice Result of Description __________________Comparison 51l0(k) Number k110945, K131344 Company ZIIAOYANG PLASTIC CO., LI) Shijiaziiuwng Wa… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K110945.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131344: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131344
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026